APX-ATENOLOL atenolol 50mg tablet blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

atenolol, Quantity: 50 mg

MAH:

Arrow Pharma Pty Ltd

pharmaceutical_form:

Tablet, film coated

composition:

Excipient Ingredients: pregelatinised maize starch; hypromellose; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; titanium dioxide; indigo carmine; methylcellulose; macrogol 400

administration_route:

Oral

units_in_package:

30 tablets

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

Atenolol is indicated in the management of: 1. All grades of hypertension, including hypertension of renal origin. 2. Frequent disabling angina without evidence of cardiac failure. 3. Cardiac arrhythmias (maintenance treatment of supraventricular and ventricular arrhythmias, including those associated with acute myocardial infarction). 4. Myocardial infarction: late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain).

leaflet_short:

Visual Identification: White, film-coated, biconvex round tablet with a breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

authorization_status:

Registered

authorization_date:

2020-04-21

PIL

APX-ATENOLOL- Consumer Medicine Information
Page 1 of 5
APX-ATENOLOL
_atenolol _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-ATENOLOL. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking APX-
ATENOLOL against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT APX-ATENOLOL IS
USED FOR
APX-ATENOLOL belongs to a group
of medicines called beta-blockers. It
works by affecting the body's
response to certain nerve impulses,
especially in the heart. As a result, it
decreases the heart's need for blood
and oxygen and therefore reduces
the amount of work the heart has to
do. It widens the blood vessels in
the body, causing blood pressure to_ _
fall. It also helps the heart to beat
more regularly.
APX-ATENOLOL is used to:_ _
•
lower high blood pressure, which
is also called hypertension
•
prevent angina (chest pain)
•
treat irregular heart rhythm or
beat such as arrhythmia
•
treat or prevent heart attacks, or
reduce your risk of heart
complications following a heart
attack
•
widen vessels in the heart which
have narrowed
HYPERTENSION:
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure)
when your blood pressure stays
higher than is needed, even when
you are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. You
may feel fine and have no
symptoms, but if high blood pressure
is not treated, it can lead to serious
health problems. APX-ATENOLOL

SPC

1
AUSTRALIAN PRODUCT INFORMATION – APX-ATENOLOL (ATENOLOL)
TABLETS
1
NAME OF THE MEDICINE
Atenolol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-ATENOLOL tablets: contain 50 mg of the active ingredient atenolol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APX-ATENOLOL tablets are white, film coated, biconvex and round with a
breakline on one face and
plain on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
All grades of hypertension, including hypertension of renal origin.
Frequent disabling angina without evidence of cardiac failure. Cardiac
arrhythmias (maintenance
treatment of supraventricular and ventricular arrhythmias including
those associated with acute
myocardial infarction).
Myocardial infarction: late intervention (
β
-blocker class effect greater than 12 hours after onset of
chest pain).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Oral.
_ADULTS_
_HYPERTENSION_: Therapy should be initiated with APX-ATENOLOL 50 mg
daily. This may be increased
each week in daily doses of 50 mg up to a maximum of 200 mg. Where
patients are controlled on
daily doses of 50 to 100 mg this may be given once daily. Doses above
100 mg daily should be given
on a divided basis. Where necessary, a further reduction in blood
pressure may be achieved by
combining APX-ATENOLOL with other antihypertensive agents.
Patients can be transferred to APX-ATENOLOL from other
antihypertensive treatments with the
exception of clonidine (see Section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
_ANGINA PECTORIS_: Therapy should be initiated with APX-ATENOLOL 50 mg
daily. This may be
increased, if required, to 100 mg daily given as a single or divided
dose. It is unlikely that additional
benefit will be gained by increasing dose.
2
_CARDIAC DYSRHYTHMIAS_: Having controlled the dysrhythmias with other
intravenous agents a suitable
oral maintenance dosage is 50 to 100 mg daily.
_ACUTE MYOCARDIAL INFARCTION_: Late Intervention (>12 hours from onset
of chest pain) Atenolol has
been sh